NCT00130650

Brief Summary

The purpose of this study is to investigate the use of a new vapocoolant spray, Pain Ease, to reduce intravenous (IV) insertion pain in school-aged children receiving treatment in the Emergency Department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

August 15, 2005

Last Update Submit

January 24, 2008

Conditions

Pain

Keywords

IVcannulationInjections, Intravenous

Outcome Measures

Primary Outcomes (1)

  • pain score

    at injection (< 1 minute)

Secondary Outcomes (4)

  • anxiety score

    at injectiong (< 1 minute)

  • satisfaction (nurse, parent)

    <10 minutes post-injection

  • IV insertion time

    immediate

  • ease of IV insertion

    immediate

Interventions

Pain EaseDEVICE

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • Require an IV inserted in less than 30 minutes

You may not qualify if:

  • Allergy to vapocoolant sprays
  • Vascular impairment
  • Diabetes mellitus
  • Developmental delay/inability to understand pain scale
  • Received analgesia in last 24 hours
  • Triaged as resuscitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

  • Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.

    PMID: 18591524DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William M Splinter, BSc, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 16, 2005

Study Start

May 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

CA(1)